Number of adverse events as a measure of safety and tolerability of a single dose of FAB117-HC when administered by intramedullary injection into the injured spinal cord

Changes from baseline in neurological function using the International Standards for Neurological Classification of SCI (ISNCSCI) scale, examinations at 24h, 72h, 7d, 14d, 28d, 90d and 360 days after injection of FAB117-HC

Number of participants that experience a decrease in severity of autonomic dysreflexia (AD) from baseline following 12-weeks of study medication.

Number of participants that experience a decrease in the frequency of autonomic dysreflexia (AD) episodes from baseline following 12-weeks of study medication.

Number of participants that experience an improvement from baseline of self-reported severity and frequency of AD as reported with the Autonomic Dysreflexia Health Related-Quality of Life (AD HR-QoL) questionnaire and reflected by a decrease in score.

(and 4 more...)

20

All

18 Years to 55 Years (Adult)

NCT02676154

H15-02364WI207218

February 2016

February 2017

October 2017

February 8, 2016

November 3, 2016

University of British ColumbiaVancouver, British Columbia, Canada

† Study has passed its completion date and status has not been verified in more than two years.